TD-1607 MAD Study in Healthy Subjects
Infections, Bacterial Infections
About this trial
This is an interventional treatment trial for Infections focused on measuring Gram-positive
Eligibility Criteria
Inclusion Criteria:
- Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
- Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.
Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.
Exclusion Criteria:
- Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
- Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
- Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
- Subject has previously participated in a trial for TD-1607.
Sites / Locations
- PPD, Phase 1 Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
TD-1607 or placebo (Dose1)
TD-1607 or placebo (Dose 2)
TD-1607 or placebo (Dose 3)
TD-1607 or placebo (Dose 4)
TD-1607 or placebo (Dose 5) [Optional]
TD-1607 or placebo (Dose 6) [Optional]
TD-1607 or placebo administered intravenously
TD-1607 or placebo administered intravenously
TD-1607 or placebo administered intravenously
TD-1607 or placebo administered intravenously
TD-1607 or placebo administered intravenously
TD-1607 or placebo administered intravenously